FDA Warning Letters, 483s and Recalls: August 2022
Warning letters
A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.
| Date | Company | Issuing office | Subject |
|---|---|---|---|
| Aug 30, 2022 | Myllan-ORA Ehf | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug 30, 2022 | TL State Management, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 29, 2022 | Vita Pharmacy, LLC Dba Talon Pharmacy Of Boerne | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| Aug 25, 2022 | Episciences Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 25, 2022 | Sree Nidhi Corp | Center for Food Safety and Applied Nutrition (CFSAN) | Foreign Supplier Verification Program (FSVP) |
| Aug 23, 2022 | BioLab Sciences, Inc. | Office of Biological Products Operations – Division 2 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Aug 23, 2022 | Jones Affiliated Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 23, 2022 | Minuti Coffee LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 23, 2022 | Visvita Corporation | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 22, 2022 | Bharat Ratan LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 19, 2022 | Green Wave Analytical, LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 18, 2022 | Countryside Feed LLC | Office of Human and Animal Food West Division II | CGMP/Animal Food/Adulterated |
| Aug 18, 2022 | National Food Industries LLC | Center for Food Safety and Applied Nutrition | Food Labeling/Misbranded |
| Aug 17, 2022 | Gordon Laboratories Inc. | Division of Pharmaceutical Quality Operations IV | Drug Product/Adulterated |
| Aug 17, 2022 | Sun Sen Co., Inc. | Office of Human and Animal Food Operations – West Division 5 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Aug 17, 2022 | Zhejiang Tianyu Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Aug 16, 2022 | JAS Diagnostics/Drew Scientific, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Aug 16, 2022 | Mexia Pallets LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 16, 2022 | Tramadol US | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
| Aug 15, 2022 | CR Grupo Comercial Alvacora S.A. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug 15, 2022 | First Strike Pet Products | Center for Veterinary Medicine | Unapproved New Animal Drug Products |
| Aug 15, 2022 | Mahi Frozen Foods | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug 15, 2022 | The Elderberry Fairy & Co., LLC | Office of Human and Animal Food Operations East Division 6 | Unapproved New Drugs/Misbranded |
| Aug 15, 2022 | Vlazar Costa Caribe S.A. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| Aug 10, 2022 | Cangene BioPharma, LLC Dba Emergent BioSolutions | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 8, 2022 | Bakkavor Foods USA Inc. | Office of Human and Animal Food Operations – East Division 3 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Aug 8, 2022 | Mina Global Trading Corp | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 8, 2022 | Oregon’S Wild Harvest, Inc. | Division of Human and Animal Food Operations West VI | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Aug 5, 2022 | Flawless Beauty And Skin | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Aug 5, 2022 | Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc. | Office of Human and Animal Food Operations – West Division 6 | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Aug 4, 2022 | Amazon.Com, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Aug 4, 2022 | Ariella Naturals | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Aug 4, 2022 | FluxxLab LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Aug 4, 2022 | JB Exchange Inc./Justified Laboratories | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| Aug 4, 2022 | Leaf Of Life LLC | Office of Human and Animal Food- West Division II | Unapproved New Drugs/Misbranded |
| Aug 3, 2022 | Blue Stone Import USA Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 3, 2022 | USA Medical LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Aug 3, 2022 | Valley Biosystems | Center for Biologics Evaluation and Research (CBER) | Bioresearch Monitoring Program |
| Aug 2, 2022 | Kuzmir Imports Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 2, 2022 | Mercado Hispano Distributors, LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 2, 2022 | Ridley USA, Inc. Dba Hubbard Feeds, Inc. | Office of Human and Animal Foods West Division II | CGMP/Animal Food/Adulterated |
| Aug 1, 2022 | DF Global, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
OAI inspections
OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.
| Date | Facility | Product type | Country |
|---|---|---|---|
| Aug 31, 2022 | APNA FOODS IMPORTS | Food/Cosmetics | United States |
| Aug 31, 2022 | J R Imports LLC | Food/Cosmetics | United States |
| Aug 29, 2022 | Amnio Technology, LLC | Biologics | United States |
| Aug 29, 2022 | Pinnacle Transplant Technologies, LLC | Biologics | United States |
| Aug 26, 2022 | Biocon Biologics Limited | Drugs | India |
| Aug 26, 2022 | Cipla Limited | Drugs | India |
| Aug 26, 2022 | Corporacion Avicola Morovis, Inc. | Food/Cosmetics | United States |
| Aug 26, 2022 | Lumene Oy | Drugs | Finland |
| Aug 26, 2022 | SALAZAR & SONS CORP | Food/Cosmetics | United States |
| Aug 26, 2022 | Ulrich Farms | Veterinary | United States |
| Aug 25, 2022 | A.P. Deauville, LLC | Drugs | United States |
| Aug 25, 2022 | Bellinger Farms LLC | Food/Cosmetics | United States |
| Aug 25, 2022 | Compass Logistics, LLC. | Food/Cosmetics | United States |
| Aug 25, 2022 | Maliba African Market Corp | Food/Cosmetics | United States |
| Aug 24, 2022 | Zing Brothers LLC | Food/Cosmetics | United States |
| Aug 23, 2022 | Livestock Nutrition Center, LLC | Veterinary | United States |
| Aug 19, 2022 | Clean Cosmetics, LLC | Drugs | United States |
| Aug 19, 2022 | Haw Par Healthcare Limited | Drugs | Singapore |
| Aug 19, 2022 | SAN-REY PRODUCE | Food/Cosmetics | United States |
| Aug 19, 2022 | Steiner Biotechnology LLC | Devices | United States |
| Aug 18, 2022 | First Choice Importing Inc. | Food/Cosmetics | United States |
| Aug 17, 2022 | 5000 Years Foods, Inc. | Food/Cosmetics | United States |
| Aug 17, 2022 | ByPro Nutrition, LLC | Food/Cosmetics | United States |
| Aug 17, 2022 | DEL VALLE IMPORT CORP. | Food/Cosmetics | United States |
| Aug 17, 2022 | DeVilbiss Healthcare LLC | Devices | United States |
| Aug 17, 2022 | Grupo Rm Usa, Inc. | Food/Cosmetics | United States |
| Aug 15, 2022 | American Cruise Lines Inc | Food/Cosmetics | United States |
| Aug 12, 2022 | Carolina Infusion, LLC | Drugs | United States |
| Aug 12, 2022 | iRhythm Technologies, Inc. | Devices | United States |
| Aug 12, 2022 | LAMBO Laboratoria | Food/Cosmetics | Belgium |
| Aug 12, 2022 | Outin Futures Corp | Drugs | Korea (the Republic of) |
| Aug 12, 2022 | RenatiLabs Inc | Biologics | United States |
| Aug 12, 2022 | Sun Pharmaceutical Industries Limited | Drugs | India |
| Aug 11, 2022 | H.E.A.L. Marketplace | Food/Cosmetics | United States |
| Aug 11, 2022 | Medivance Instruments Ltd. | Devices | United Kingdom |
| Aug 10, 2022 | Atlantic Management Resources Ltd. | Drugs | United States |
| Aug 10, 2022 | M. Fierro & Sons, LLC | Food/Cosmetics | United States |
| Aug 9, 2022 | Fairy Tales Hair Care Inc. | Drugs | United States |
| Aug 9, 2022 | Profounda Inc | Drugs | United States |
| Aug 5, 2022 | Bravo Packing, Inc. | Veterinary | United States |
| Aug 5, 2022 | Empower Clinic Services LLC | Drugs | United States |
| Aug 5, 2022 | ImprimisRx NJ LLC | Drugs | United States |
| Aug 5, 2022 | Midlab Incorporated | Drugs | United States |
| Aug 5, 2022 | Mike T. Millenkamp | Veterinary | United States |
| Aug 5, 2022 | Samuel P. Hostetler | Food/Cosmetics | United States |
| Aug 4, 2022 | Euphoria Fancy Food Inc | Food/Cosmetics | United States |
| Aug 3, 2022 | Facema, LLC. | Food/Cosmetics | United States |
| Aug 2, 2022 | Consolidated Chemical, Inc | Drugs | United States |
| Aug 2, 2022 | Titans Global Inc. | Food/Cosmetics | United States |
| Aug 1, 2022 | EL MAGUEY DORADO CORPORATION | Food/Cosmetics | United States |
| Aug 1, 2022 | Frenda Corporation | Drugs | United States |
| Aug 1, 2022 | FUENTES FARMS LLC | Food/Cosmetics | United States |
| Aug 1, 2022 | Jubilant Generics Limited | Drugs | India |
Most-cited Form 483 sections
The CFR sections FDA investigators cited most often in inspections that ended this month.
| CFR section | Observation | Citations |
|---|---|---|
| 21 CFR 1.502(a) | Develop FSVP | 91 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 41 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 28 |
| 21 CFR 117.10 | Personnel | 22 |
| 21 CFR 211.192 | Written record of investigation incomplete | 21 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 20 |
| 21 CFR 117.35(c) | Pest control | 19 |
| 21 CFR 123.6(b) | No HACCP plan | 16 |
| 21 CFR 117.20(b) | Plant construction and design | 15 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 15 |
Class I recalls
Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.
| Date | Firm | Product type | Reason |
|---|---|---|---|
| Aug 29, 2022 | Albertsons Companies LLC | Food | Undeclared allergen; fish (anchovy) |
| Aug 29, 2022 | BEST NUTRITIONALS LLC | Food | Best Nutritionals LLC 120 Centennial Ave, Piscataway NJ 08854, is initiating a recall of Fenugreek 610 mg , 360 Capsules ,in White Plastic… |
| Aug 29, 2022 | TELEFLEX LLC | Devices | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | TELEFLEX LLC | Devices | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | TELEFLEX LLC | Devices | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | TELEFLEX LLC | Devices | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | TELEFLEX LLC | Devices | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | TELEFLEX LLC | Devices | Incidents of device splitting or detaching during use |
| Aug 26, 2022 | Philips Respironics, Inc. | Devices | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| Aug 26, 2022 | Philips Respironics, Inc. | Devices | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| Aug 26, 2022 | Philips Respironics, Inc. | Devices | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| Aug 26, 2022 | Philips Respironics, Inc. | Devices | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| Aug 26, 2022 | Philips Respironics, Inc. | Devices | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| Aug 26, 2022 | Philips Respironics, Inc. | Devices | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| Aug 26, 2022 | St. James Smokehouse, Inc. | Food | Possible contamination with Listeria monocytogenes |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Keswick Creamery At Carrock Farms LLC | Food | All products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. |
| Aug 25, 2022 | Tai Phat Wholesalers LLC | Food | Products were found to be contaminated with Salmonella. |
| Aug 25, 2022 | Tai Phat Wholesalers LLC | Food | Products were found to be contaminated with Salmonella. |
| Aug 25, 2022 | Tai Phat Wholesalers LLC | Food | Products were found to be contaminated with Salmonella. |
| Aug 25, 2022 | Tai Phat Wholesalers LLC | Food | Products were found to be contaminated with Salmonella. |
| Aug 23, 2022 | Kenover Marketing Corp. | Food | Kenover Marketing, 72 New Hook, Bayonne NJ, 07002, has initiated a recall of Mighty Sesame 10.9 Oz Organic Tahini (Squeezable)… |
| Aug 22, 2022 | Pfizer Inc. | Drugs | Presence of particulate matter |
| Aug 18, 2022 | Scone Ranger Inc | Food | Undeclared milk. Vegan scones contain margarine but labeling does not declare margarine or milk. |
| Aug 18, 2022 | Scone Ranger Inc | Food | Undeclared milk. Vegan scones contain margarine but labeling does not declare margarine or milk. |
| Aug 16, 2022 | West Thomas Partners, LLC. Dba Gluten Free Bar | Food | Undeclared cashews |
| Aug 15, 2022 | Epicurean Butter Co. | Food | Firm's supplier of frozen dill notified firm of a recall due to potential contamination with Listeria monocytogenes. |
| Aug 15, 2022 | GC FOOD FACTORY, LLC | Food | Undeclared Wheat |
| Aug 11, 2022 | EZ Noble Sushi | Food | Contains undeclared egg. |
| Aug 11, 2022 | EZ Noble Sushi | Food | Contains undeclared egg. |
| Aug 11, 2022 | EZ Noble Sushi | Food | Contains undeclared wheat. |
| Aug 11, 2022 | EZ Noble Sushi | Food | Contains undeclared wheat. |
| Aug 11, 2022 | EZ Noble Sushi | Food | Contains undeclared egg. |
| Aug 11, 2022 | EZ Noble Sushi | Food | Contains undeclared egg and wheat |
| Aug 11, 2022 | EZ Noble Sushi | Food | Contains undeclared egg. |
| Aug 11, 2022 | Max's Bakery And Kitchen | Food | Proposition Chicken Ranch Dressing contains IQF Dill which is an ingredient recalled due to the presence of Listeria Monocytogenes. |
| Aug 11, 2022 | Raw Seafoods Inc. | Food | Firm used dill recalled for Listeria monocytogenes to product butter pucks |
| Aug 11, 2022 | Supherb Farms | Food | RTE Frozen Dill is being recalled after a customer tested product and Listeria Monocytogenes was found to be present |
| Aug 9, 2022 | Baxter Healthcare Corporation | Devices | Firm noted an increase in customer reports of leaks. |
| Aug 9, 2022 | DEWEI MEDICAL EQUIPMENT CO LTD | Devices | Products were distributed in the United States without FDA authorization or clearance. |
| Aug 9, 2022 | Fifth Season | Food | Undeclared milk and eggs |
| Aug 9, 2022 | Jiangsu Well Biotech Co.,Ltd. | Devices | Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance. |
| Aug 5, 2022 | Blue Diamond Growers | Food | Firm's internal sampling identified a positive Salmonella result on Item 00113 that was on hand at the firm on 7/15/2022. Firm elected to… |
| Aug 2, 2022 | Royal Crest Dairy, Incorporated | Food | Potential Egg Allergen contamination of Chocolate Milk. |
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